Catalog Number

OD018

Brand Name

N/A

Version/Model Number

OD018

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2019

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K093236,K093236

Product Code

KNQ

Product Code Name

Dilator, esophageal

Public Device Record Key

c7213325-8a0c-497e-abc6-6c1a0ece2ba3

Public Version Date

March 01, 2019

Public Version Number

5

DI Record Publish Date

July 15, 2016

Package DI Number

30705036003902

Quantity per Package

14

Contains DI Package

20705036003905

Package Discontinue Date

February 28, 2019

Package Status

Not in Commercial Distribution

Package Type

CASE